This funding opportunity announcement (FOA) supports high
impact efforts to make resources available to neuroscience researchers.
Projects should engage in one or more of the following activities:
propagation of cutting edge reagents or techniques, dissemination of
resources to new user groups, or innovative approaches to increase the
scale/efficiency of resource production and delivery. Applications focused
on technology or software development are not responsive to this FOA, as the
focus is on dissemination or provision of resources. Use of existing
technologies to develop new reagents or genetic lines of clear value may be
appropriate. Projects should address compelling needs of broad communities
of neuroscience researchers or should offer unique services that otherwise
would be unavailable. Projects must support the NINDS mission.

Key Dates

Posted Date

March 27, 2014

Open Date (Earliest Submission Date)

(New Date September 20, 2014 per NOT-NS-14-034), Originally May 23, 2014

Letter of Intent Due Date(s)

(New Date September 20, 2014 per NOT-NS-14-034), Originally May 23, 2014

Application Due Date(s)

(New Date October 20, 2014 per NOT-NS-14-034), Originally June 23, 2014, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

(New Date October 21, 2014 per NOT-NS-14-034), Originally June 24, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

Research project grants such as the R01 provide funding for
development of new technologies and resources. However, funding opportunities
for making resources available to the research community are more limited, even
though such activities can be critical for research progress. The goal of
this FOA is to address this need by supporting innovative and high impact
projects to make resources, tools and techniques available to neuroscience
researchers.

Projects responsive to this FOA should engage one or more of
the following types of activities:

Propagation of newly developed, cutting edge reagents or
techniques that are not widely available or easily obtained

Broadening the impact of important existing resources by bringing
them to new user groups for whom access would not otherwise be available

Innovative approaches to increase the scale and efficiency of
existing valuable resources.

The following categories of resources may be appropriate for
this FOA, provided that the proposed resource concords with the types of high
impact activities described above: Animal models, Animal Surgery, Behavioral
Testing, Specialized Cell Culture, Histochemistry, Specialized Imaging or
Microscopy, Pathology, Physiology, and Statistical/Computational
Analysis.

Applicants are strongly encouraged to contact NINDS Program
staff and/or the Scientific/Research Contact for this FOA (Section
VII, below) to discuss the potential relevance of a particular resource to
this FOA.

Scope

Proposed projects must plan to substantially impact the
quality of neuroscience research by virtue of the provided resources.
Existing efforts are not responsive to this FOA unless the application proposes
specific plans for new high impact activities that would not otherwise be
feasible.

Efforts must be in support of the NINDS mission, which is to
reduce the burden of neurological disease. In pursuit of this mission,
NINDS supports research on the normal and diseased nervous system, including
basic cellular/molecular biology and genetics, research in cognitive/behavioral
and systems neuroscience, neuroplasticity, neurodevelopment, neurodegeneration,
and studies aimed at detection, prevention, and treatment of neurological
diseases. For more information on NINDS research funding listed by
Program Area, see http://www.ninds.nih.gov/funding/areas/index.htm.

Projects must be specifically targeted to neuroscience
research. Resources and techniques that are general to biomedical
sciences are not responsive to this FOA, unless there is a specific unmet
neuroscience research need.

The following activities are not responsive to this FOA.

Projects focused on technology development are not responsive to
this FOA. Applicants considering such efforts are encouraged to contact an
appropriate NINDS Program Director to discuss alternative grant
mechanisms. Use of existing technologies to develop new reagents, such as
genetic lines or constructs, may be appropriate for this FOA, but clear value
to the intended user group must be demonstrated in the application.

Projects focused solely on software development are not
responsive to this FOA. Applicants considering software development efforts
can find information on current funding announcements and NIH Program contacts
at the Biomedical Information Science and Technology Initiative (BISTI) website
(http://www.bisti.nih.gov).

Projects that support clinical trials or provide patient services
are not responsive to this FOA. For services associated with clinical
research, investigators should contact the NINDS Office of Clinical Research (http://www.ninds.nih.gov/research/clinical_research/).

Projects proposing repositories of brain and related
bio-specimens are not responsive to this FOA, as described in NOT-MH-12-020.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The NINDS intends to commit an estimated $1,200,000 in FY
2014 for approximately five awards, but the number of awards is contingent
upon NIH appropriations, and the submission of a sufficient number of
meritorious applications.

Award Budget

Projects must average no more than $175,000 per year
direct cost (excluding consortium Facilities and Administrative costs). In
any given year, up to $350,000 direct cost may be requested as long as the
total direct costs for all years does not exceed $700,000

Award Project Period

Support may be requested for up to four years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants must
have an active DUNS number and SAM registration in order to complete the eRA
Commons registration. Organizations can register with the eRA Commons as they
are working through their SAM or Grants.gov registration. eRA Commons requires
organizations to identify at least one Signing Official (SO) and at least one
Program Director/Principal Investigator (PD/PI) account in order to submit an
application.

Grants.gov – Applicants must
have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

While the Research Strategy is limited to 12 pages, it is
highly recommended that this section be no more than 6 pages.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some components
marked optional in the application package are required for submission of
applications for this FOA. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Biographical
Sketch: In the Personal Statement section of the Biographical
Sketch, describe why the experiences and qualifications of the PD(s)/PI(s) make
them particularly well-suited for their role(s) in the project. Include any
history of service-oriented efforts outside the needs of their own
research. Provide evidence that the PD(s)/PI(s) are well-positioned to
provide the proposed resource, and to integrate the project with broader
strategic interests of potential users on a national and international
scale.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Research
Strategy: The Research Strategy section must include the
following required information.

Milestones: Applications must propose quantitative
interim milestones that will serve as reliable indicators for objective
evaluation of progress over the course of the project. The milestones
should include realistic quantitative goals for resource usage, which will be
reported at the end of a given annual funding period. At a minimum,
specific milestones must be proposed for the end of the second year, and in most
cases annual milestones may be appropriate. NINDS Program staff will use
the project milestones for evaluation of the funded award, to determine whether
to continue the award in subsequent years.

Strategic Vision: Project PD(s)/PI(s) should strive to
integrate their efforts with broader strategic interests of potential users on
a national and international scale.

Governance: A Steering Committee providing guidance and
feedback should be proposed, and should include senior researchers with
relevant technical and scientific expertise. The composition of this
committee depends on the nature and scope of the project, and the committee may
include, as appropriate to the project, individuals employed by the PD/PI's
institution.

Access and Prioritization: Projects should include
mechanisms for thorough dissemination and advertisement of available services
and resources to the full community of neuroscience investigators, consistent
with achieving the goals of this program. A concrete Project
Prioritization Plan should be provided, detailing how the capacity of the
proposed resource will be evaluated and allocated. Prioritization may be
established by virtue of a fee structure or by a formal project evaluation
mechanism, or by other appropriate considerations.

Note:
Resources are expected to be free from any patent or licensing constraints that
would unduly restrict academic research use and impede achieving the goals of
this funding program. For resources requiring material from human subjects
(e.g. DNA, fibroblasts, blood, tissue etc.), broad sharing of the resource and
any derivatives with academic and industry investigators is consistent with
achieving the goals of this program and also would need to be consistent with
applicable laws, regulations, and informed consents.

Cost Offsets: Cost offsets via user fees are not
required, but they should be considered as part of the project plan, since they
provide potential mechanisms for efficient resource allocation and for resource
sustainability.

Letters
of Support: Letters of support from potential resource users
are strongly encouraged. Users' research plans should be provided with a
level of detail sufficient for reviewers to assess the potential impact of the
proposed resource.

The Letters of Support section of the application should
include a cover page listing the name, institution, and proposed role for each
individual providing a letter of support.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions
for completing Planned Enrollment Reports as described in the SF424 (R&R)
Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing Cumulative Inclusion Enrollment Report
as described in the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by NINDS, NIH. Applications that are
incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Will the proposed resource contribute substantially
to the quality of neuroscience research? Will it convincingly add major
value over any comparable facilities and services? Will the resource
support research projects of the highest quality and significance in their
respective fields?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Do the PD(s)/PI(s) have a history of service-oriented
efforts outside the needs of their own research? Are they uniquely
positioned to provide the proposed resource, and to integrate their efforts
with broader strategic interests of potential users on a national and
international scale?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?

Are the proposed Milestones, Strategic Vision,
Governance, Access and Prioritization, and Cost Offset plans appropriate for
the project?

If the project involves human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion or exclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of
children to determine if it is justified in terms of the scientific goals and
research strategy proposed. For additional information on review of the
Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to comments
from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NINDS, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the National Advisory Neurological Disorders and Stroke (NANDS) Council.
The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH Grants
Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.